21 CFR 211.44 - Lighting

What it says

Adequate lighting must be provided in all areas of the facility. The requirement is short, but it supports the ability of personnel to see what they are doing, to clean effectively, to read labels and instruments, and to carry out visual inspections.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Light levels should be sufficient for the task, with more attention to areas such as inspection stations, labeling and weighing.
• Burned-out or poorly placed lights can hide dirt, spills and defects, so lighting should be maintained.
• Fixtures in production areas should be suitable for the room classification and easy to clean.

What FDA inspectors look for

• Whether lighting is adequate in processing, packaging, storage and cleaning areas.
• Whether inspection steps are done under suitable lighting.
• Whether light fixtures are intact and maintained.

Related regulations